Stability studies are indispensable during the development of protein formulations. They are conducted inter alia to define the optimal storage conditions and expiration date of the final product.
To accelerate stability determinations, protein stability studies are often conducted at elevated temperatures. The key issue in interpreting the results of such accelerated protein stability studies is whether the data from accelerated studies can be extrapolated to those under real-time conditions.
Very often accelerated protein stability studies are performed at 40° C. Extrapolation of protein stability at temperatures different from that is based on an Arrhenius plot, wherein linearity of the Arrhenius plot is assumed. However, since protein stability Arrhenius plots in reality are often not linear at higher temperatures, this method can lead to wrong results.
Therefore, a need exists in the field to provide a method for determining the highest temperature that is suitable for performing accelerated protein stability studies. Further, a need exists in the field to improve current methods for modeling real-time protein stability from accelerated stability data, in order to achieve more accurate and reliable results.